EP0606392B1 - Vaso-occlusion coil with attached fibrous element(s) - Google Patents

Vaso-occlusion coil with attached fibrous element(s) Download PDF

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Publication number
EP0606392B1
EP0606392B1 EP92922060A EP92922060A EP0606392B1 EP 0606392 B1 EP0606392 B1 EP 0606392B1 EP 92922060 A EP92922060 A EP 92922060A EP 92922060 A EP92922060 A EP 92922060A EP 0606392 B1 EP0606392 B1 EP 0606392B1
Authority
EP
European Patent Office
Prior art keywords
coil
windings
length
fibrous element
fibrous
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP92922060A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0606392A1 (en
EP0606392A4 (en
Inventor
U. Hiram Chee
Mike Mariant
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Target Therapeutics Inc
Original Assignee
Target Therapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Target Therapeutics Inc filed Critical Target Therapeutics Inc
Publication of EP0606392A1 publication Critical patent/EP0606392A1/en
Publication of EP0606392A4 publication Critical patent/EP0606392A4/en
Application granted granted Critical
Publication of EP0606392B1 publication Critical patent/EP0606392B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Definitions

  • This invention is in the field of vasoocclusion devices. More particularly it relates to a vasoocclusion coil to which fibrous elements are attached.
  • Vasoocclusion devices are surgical implements that are placed within vessels, typically via a catheter to block the flow of blood through the vessel.
  • One type of prior art vasoocclusive device, upon which the preamble of claim 1 is based, is a helical wire coil that has windings that are dimensioned to engage the walls of the vessels. Fibers are laid crosswise through the windings to provide a substrate for embolization within the vessel. Coils of such structure are available commercially from Cook, Inc.
  • US-A-4,994,069 describes a vasoocclusive coil that assumes a linear helical configuration when stretched and a folded convoluted configuration when relaxed. The stretched condition is used in placing the coil at the desired site and the coil assumes its relaxed configuration (which is better suited to occlude the vessel) once the device is so placed.
  • a vaso-occlusive device comprising:
  • helical vaso-occlusion coils to which fibrous elements are attached in a manner that ensures they will not be dislodged from the coil and which enhances the ability of the coil to facilitate embolization.
  • Figs. 1 to 11 are fragmentary elevational views (not to scale) of embodiments of the helical coil of the invention.
  • Figs. 1 and 2 show the specific manner of connecting the fibres to the coils.
  • Fig. 1 depicts one embodiment, generally designated 10, of the vaso-occlusive coil of the invention.
  • the device 10 has two components: a helical coil 11; and a fibrous element 12.
  • Coil 11 will typically be made of a radiopague material such as platinum, tungsten, gold, stainless steel, or of alloys such as tungsten and platinum.
  • a tungsten-platinum alloy is preferred because of its strength and toughness.
  • the material desirably is radiopaque and the diameter of the wire will usually be in the range of 0.05 to 0.25 mm.
  • the coil has a multiplicity of individual windings 13.
  • the axial length of the coil will usually be in the range of 0.2 to 100 cm, more usually 0.2 to 40 cm and the diameter of the coil will normally be 0.015 to 0.1 cm, more usually 0.025 to 0.1 cm.
  • the coil will typically have about 10 to 70 windings per cm, more typically about 10 to 40 windings per cm.
  • the wire diameter of radiopaque coil 11 may be in the range of 0.05 to 0.25 mm.
  • the coil has a multiplicity of individual windings 13.
  • the axial length of the coil will usually be in the range of 0.2 to 100 cm, more usually 0.2 to 40 cm and the diameter of the coil will normally be 0.05 to 0.2 cm, more usually 0.05 to 0.15 cm.
  • the coil will typically have about 5 to 70 windings per cm, more typically about 5 to 40 windings per cm. Such coils are especially suitable where large diameter coils or high strength coils are desirable, e.g., in large vessel occlusion.
  • the fibrous element 12 may be a bundle of individual fibers 14 (typically 5 to 100 fibers per bundle, preferably 20 to 30 fibers per bundle) as shown in Fig. 1 or a monofilament 15 as shown in Fig. 2.
  • the fibers may be made from biocompatible materials such as Dacron (polyester), polyglycolic acid, polylactic acid, fluoropolymer (polytetrafluoroethylene), nylon (polyamide), or silk.
  • end 16 of the bundle is tied to winding 17 of the coil by a knot 18. Knotting at the ends of the bundle is desirable, but not essential, as the threading of the loops about the windings (see below) is sufficient to anchor the bundle to the coil.
  • the specific location of attachment of end 16 is not critical and it will typically be either at the proximal end 18 of the coil or at a site on the coil spaced from the proximal end a distance greater than the loop length (see below) when the loop is lying flat on the coil.
  • the fiber bundle extends in a generally serpentine or sinusoidal wave configuration along the exterior of the coil in a series of outer-directed (relative to the coil axis) loops 19 and inner-directed loops 20.
  • the inner-directed loops are threaded about individual windings, designated 21, 22, 23 and 24 at spaced intervals (indicated as distance "a" between knot 18 and winding 21) along the coil.
  • the individual windings are shown in a slightly expanded (spaced) condition for the purposes of illustration. More normally, however, the windings will be closer together so that the windings on either side of windings 21, 22, 23 and 24 pinch the fiber bundle against windings 21, 22, 23 and 24.
  • the length of the intervals ("a") between the windings about which the fiber bundle passes may vary. It will typically be about 0.05 to 1 cm. The interval spacing may be the same or different along the length of the coil.
  • the loop length (e.g., the curvilinear length of the bundle from knot 18 to winding 21) may vary and may be the same or different from loop-to-loop.
  • the loop length will normally be 0.1 to 2 cm, more usually 0.1 to 0.5 cm.
  • the fibrous element will usually extend between about 10% to 90% of the total axial length of coil.
  • the axial distance over which the element extends will usually be 0.05 to 90 cm, more usually 0.05 to 15 cm.
  • the dashed lines in the drawings indicate that the coil extends distally.
  • the element will typically be located at the proximal end of the wire.
  • proximal is relative to orientation in which the coil is loaded within a catheter.
  • the distal end of the element is affixed by knot 25 to winding 26.
  • Fig. 1 depicts a coil with only a single affixed fiber bundle, it will be appreciated that a multiplicity (typically 2 to 4) of fiber bundles may be similarly attached at spaced intervals about the circumference of the coil.
  • Fig. 2 illustrates another embodiment, generally designated 30, of the vasoocclusive device of the invention.
  • the fibrous element in Fig. 2 is a monofilament 15 and (2) there are two monofilaments 15 attached to the coil rather than a single fibrous element. As shown, the two monofilaments are spaced approximately 180° apart about the circumference of the coil. As in the case of device 10, additional monofilaments 15 may be affixed to the coil if desired.
  • Figs. 3 to 11 show variants of the invention, but for simplicity of explanation, show the shape during introduction (Figs. 3 and 9) or after introduction (Figs. 4, 5, 6 to 8, 10 and 11) but without the invention fibers attached.
  • the fibers are attached in the same way and in the same configuration as is shown in Figs. 1 and 2.
  • Fig. 3 shows a partial side view of the helical coil 40 in the configuration found during installation.
  • the coil 40 will be placed on a wire core, which is interior to a catheter, which wire will hold the coil 40 in a linear form until discharged from the end of the wire.
  • Fig. 4 shows the coil of Fig. 3 after it has been released from the end of the guide or core wire.
  • the coil loops back upon itself to form a secondary coil having a diameter 42.
  • the secondary coil diameter 42 may be up to the size of the vessel to be occluded.
  • Fig. 5 shows the coil of Fig. 3 in which the coil has irregularities in the coil windings allowing formation of the folded convoluted conformation in the coil's relaxed condition.
  • the multiple convolutions or irregularities in the embodiment are such as to offset the helical axis (the arrows in the Fig. 4) of each winding by 20-40 degrees.
  • Figs. 6, 7, and 8 each illustrate a different aspect of the invention.
  • Fig. 1 and Fig. 2 show helical coils that are linear in shape
  • Figs. 6-8 show differently-shaped coils that are useful in the invention.
  • Fig. 6 shows a cloverleaf-shaped vasoocclusive coil
  • Fig. 7 shows a figure-8-shaped
  • Fig. 8 shows a C-shaped vasoocclusive coil.
  • the fibers attached to these coils are analogous to the fibers attached to the coils in Fig. 1 and Fig. 2.
  • Figures 9 and 10 show a vasoocclusive coil such as is found above, but in which irregularities in the helical winding are produced by flattening the wire coil in different directions. This may be accomplished by flattening or squeezing the linear coil 50 in a number of places 52 along the winding at various angles (if so desired) such as shown in Fig. 9.
  • the coil so formed will have the general appearance shown in Fig. 9 when in its linear configuration and those shown in Fig. 10 in its relaxed configuration.
  • the flattened portions of the coil 52 must be smaller in diameter than the inner diameter of the catheter through which it must pass.
  • Fig. 11 shows a coil having a primary coil structure as described above, with a helical winding 54 having at least one helical turn whose diameter 56 is the size of the vessel to be occluded.
  • the irregularities in the helical winding take the form of continually changing helical diameters forming spirals which are dimensioned to span the cross-sectional area of the vessel.
  • each of the variations shown in Figs. 3 to 11 include the fibers independently shown in Figs. 1 or 2.
  • the vasoocclusion coils of this invention are used in a manner similar to the coil of U.S. 4,994,069. Briefly, the coil is preferably supplied in prepackaged form in a sterile cannula which is adapted to engage the proximal end of a catheter. The loops of the fibrous bundle will be pressed flat against the coil for placement in the cannula and catheter. Once the catheter is in place within a vessel, the coil-containing cannula is placed into engagement with the proximal end of the catheter and the coil is transferred from the cannula lumen into the catheter lumen by exerting force on the proximal end of the coil. A pusher rod is used to push the coil through the catheter to the desired coil release site. The location of the coil may be visualized due to the radiopacity of the helical coil. Once at the site, the coil is plunged from the catheter lumen into the vessel. This allows the flexible fiber loops to extend outwardly from the coil surface to fill the vessel.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Reproductive Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • External Artificial Organs (AREA)
  • Investigating Or Analyzing Materials By The Use Of Magnetic Means (AREA)
  • Burglar Alarm Systems (AREA)
  • Glass Compositions (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
  • Magnetic Treatment Devices (AREA)
  • Television Systems (AREA)
  • Measurement Of Length, Angles, Or The Like Using Electric Or Magnetic Means (AREA)
  • Electrotherapy Devices (AREA)
  • Circuits Of Receivers In General (AREA)
  • Switches That Are Operated By Magnetic Or Electric Fields (AREA)
  • Electromagnets (AREA)
  • Ignition Installations For Internal Combustion Engines (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Absorbent Articles And Supports Therefor (AREA)
  • Cookers (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Separation By Low-Temperature Treatments (AREA)
EP92922060A 1991-10-02 1992-10-01 Vaso-occlusion coil with attached fibrous element(s) Expired - Lifetime EP0606392B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US771013 1991-10-02
US07/771,013 US5226911A (en) 1991-10-02 1991-10-02 Vasoocclusion coil with attached fibrous element(s)
PCT/US1992/008335 WO1993006884A1 (en) 1991-10-02 1992-10-01 Vaso-occlusion coil with attached fibrous element(s)

Publications (3)

Publication Number Publication Date
EP0606392A1 EP0606392A1 (en) 1994-07-20
EP0606392A4 EP0606392A4 (en) 1994-08-17
EP0606392B1 true EP0606392B1 (en) 1997-03-05

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP92922060A Expired - Lifetime EP0606392B1 (en) 1991-10-02 1992-10-01 Vaso-occlusion coil with attached fibrous element(s)

Country Status (19)

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US (1) US5226911A (cs)
EP (1) EP0606392B1 (cs)
JP (1) JPH0763508B2 (cs)
KR (1) KR0126071B1 (cs)
AT (1) ATE149359T1 (cs)
AU (2) AU2686292A (cs)
CA (1) CA2084749C (cs)
CZ (1) CZ280038B6 (cs)
DE (1) DE69217975T2 (cs)
DK (1) DK0606392T3 (cs)
ES (1) ES2101122T3 (cs)
FI (1) FI941499L (cs)
HU (1) HUT68205A (cs)
IL (2) IL103240A0 (cs)
NO (1) NO300484B1 (cs)
NZ (1) NZ244607A (cs)
PT (1) PT100927A (cs)
TW (1) TW259698B (cs)
WO (2) WO1993006883A1 (cs)

Cited By (2)

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US7763077B2 (en) 2003-12-24 2010-07-27 Biomerix Corporation Repair of spinal annular defects and annulo-nucleoplasty regeneration
US7803395B2 (en) 2003-05-15 2010-09-28 Biomerix Corporation Reticulated elastomeric matrices, their manufacture and use in implantable devices

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US6083220A (en) 1990-03-13 2000-07-04 The Regents Of The University Of California Endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas
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AU661871B2 (en) 1995-08-10
DE69217975T2 (de) 1997-06-12
IL103240A0 (en) 1993-02-21
EP0606392A1 (en) 1994-07-20
CZ280038B6 (cs) 1995-10-18
NZ244607A (en) 1994-08-26
CA2084749A1 (en) 1993-04-03
JPH0763508B2 (ja) 1995-07-12
IL103328A (en) 1995-12-08
EP0606392A4 (en) 1994-08-17
PT100927A (pt) 1994-06-30
DK0606392T3 (da) 1997-07-28
HUT68205A (en) 1995-06-28
FI941499A0 (fi) 1994-03-30
AU2868692A (en) 1993-05-03
IL103328A0 (en) 1993-03-15
NO941061D0 (no) 1994-03-23
NO941061L (no) 1994-03-23
WO1993006883A1 (en) 1993-04-15
HU9400961D0 (en) 1994-06-28
CZ66694A3 (en) 1994-06-15
FI941499A7 (fi) 1994-05-16
ES2101122T3 (es) 1997-07-01
ATE149359T1 (de) 1997-03-15
US5226911A (en) 1993-07-13
KR0126071B1 (ko) 1997-12-19
TW259698B (cs) 1995-10-11
WO1993006884A1 (en) 1993-04-15
JPH06506622A (ja) 1994-07-28
AU2686292A (en) 1993-05-03
CA2084749C (en) 1994-09-27
NO300484B1 (no) 1997-06-09
FI941499L (fi) 1994-05-16
DE69217975D1 (de) 1997-04-10

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